Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women

Phase

N/A

Condition

Lactose Intolerance

Constipation

Colic

Treatment

Dietary supplement for digestive health

placebo capsule

Clinical Study ID

NCT07215351

PRO-FY2025-554

Ages > 18
All Genders
Accepts Healthy Volunteers

Study Summary

The purpose of the present study is to investigate the impact of a natural dietary supplement, Inno Cleanse™, to reduce bloating in a population of otherwise healthy men and women, who claim to feel frequently bloated. Inno CleanseTM dietary supplement is manufactured in the United States under current Good Manufacturing Practices (cGMP) and is marketed by InnoSupps as a digestive health aid. It is sold in the United States on the company's website, Amazon, and in many large retail outlets. It remains a very popular product, with close to 1.4 million units sold since 2020, with a reported 66,000 units sold in the past three months.

Despite the prevalence of dietary supplements identifying as digestive aids, detoxification, and cleanses, very little research has been done to determine their effectiveness. The product appears to be well-designed, with multiple ingredients included which have scientific evidence of effectiveness. That said, and despite the overall positive reviews, there is no known clinical research to support the product's effectiveness.

Therefore, the aim of this study is to evaluate the efficacy of the Inno Cleanse product to reduce bloating and result in other positive outcomes (weight loss). This study will be run as a double-blind placebo-controlled trial, in which subjects will use the product or placebo for two weeks. It is hypothesized that treatment with the dietary supplement Inno Cleanse will result in reduced bloating, as evidenced by self-reported reductions in bloating and hunger, as well as moderate weight loss and a reduction in body circumference measures due to the reduced bloating. In addition, multiple anecdotal reports of improved skin health have been noted in those using the product. Additionally, routine blood and urine sample analysis will be performed as a secondary outcome, as a safety measure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

experience regular (2 or more days per week) bloating or constipation
able to fast a minimum of 12 hours prior to testing visit

Exclusion

Exclusion Criteria:

pregnant, planning to become pregnant, or breastfeeding
sensitivity or allergic to any components of the study product (cascara sagrada barkpowder, cape aloe leaves extract, senna leaf powder, frangula bark powder fennelseed powder, bentonite clay, burdock root powder, licorice root extract, slipperyelm bark powder, Capiscum annuum L. Fruit powder, milk thistle seed powder,hydroxypropyl methylcellulose, cellulose, and silicon dioxide).
experienced a severe allergic reaction that resulted in emergency care
diagnosed with medical disorders linked to digestive/gut health such as celiacdisease, crohn's disease, gastroesophageal reflux disease, heartburn, irritablebowel syndrome, ulcerative colitis, ulcers, etcetera.
experiencing regular diarrhea
active infection or illness
diabetic
hypertensive
cardiovascular disease
breast, uterine, or ovarian cancer
uterine fibroids or endometriosis
taking medications or supplements that may alter gut health including but notlimited to diuretics, laxatives, anti-diarrheal, anticholinergic agents, orantispasmodic agents.
previous adverse experience with laxatives
taking medications known to interact with the dietary supplement's ingredientsincluding blood pressure medications, anticoagulants, antiplatelets, blood thinners,cholesterol-lowering medications, diuretics, water pills, estrogen basedcontraceptives, non-steroidal anti-inflammatory drugs, digoxin, corticosteroids,Monoamine oxidase inhibitors, insulin, medications processed in the liver,diclofenac, fluvastatin, glipizide, ibuprofen, piroxicam, phenytoin, phenobarbital,or secobarbital.
tobacco user
strenuous activity within 24 hours of testing visits
caffeine within 24 hours of testing visit
alcohol within 24 hours of testing visit

Study Design